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Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00822692
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : September 3, 2009
Last Update Posted : December 21, 2015
Sponsor:
Collaborators:
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Information provided by (Responsible Party):
Gillian Schmitz, 59th Medical Wing

Brief Summary:
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

Condition or disease Intervention/treatment Phase
Abscess Methicillin-Resistant Staphylococcus Aureus Infection Drug: Trim/ Sulfa DS Drug: placebo Not Applicable

Detailed Description:
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess MRSA

Arm Intervention/treatment
Active Comparator: Bactrim DS
Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
Drug: Trim/ Sulfa DS
bactrim DS (800/160) two tablets PO BID x 7 days
Other Name: Bactrim

Placebo Comparator: matched placebo
matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
Drug: placebo
matched placebo 2 pills PO BID x 7 days




Primary Outcome Measures :
  1. Recurrence Rates of Abscesses [ Time Frame: 30 days after incision and drainage ]
    Number of patient with a new abscess in same or different location as previous lesion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

  • Patients with diabetes, HIV, cancer or other immunocompromised patients.
  • Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
  • Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
  • Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
  • Finally, patients with sulfa allergy will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822692


Locations
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United States, Texas
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
59th Medical Wing
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Investigators
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Principal Investigator: Gillian R Schmitz 59th Medical Wing
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gillian Schmitz, Emergency Physician, 59th Medical Wing
ClinicalTrials.gov Identifier: NCT00822692    
Other Study ID Numbers: FWH20080055H
First Posted: January 14, 2009    Key Record Dates
Results First Posted: September 3, 2009
Last Update Posted: December 21, 2015
Last Verified: December 2015
Keywords provided by Gillian Schmitz, 59th Medical Wing:
Abscess
Cellulitis
Antibiotics
MRSA
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Staphylococcal Infections
Abscess
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Suppuration
Inflammation
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents